U.S. patent number 10,912,918 [Application Number 16/827,276] was granted by the patent office on 2021-02-09 for pre-lubricated female urinary catheter package.
This patent grant is currently assigned to Cure Medical LLC. The grantee listed for this patent is Cure Medical LLC. Invention is credited to Timothy A. Palmer.
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United States Patent |
10,912,918 |
Palmer |
February 9, 2021 |
Pre-lubricated female urinary catheter package
Abstract
A rigid package or container for a sterile pre-lubricated, ready
to use female-length catheter with enhanced gel receptacles and
simple constructions. A main body of the rigid container has a
hollow interior which may receive a gel receptacle defining an
inner cavity filled with a lubricating gel. The gel receptacle
partly inserts into the main body and a tube of the catheter
inserts through the gel receptacle into the main body with a
proximal outlet projecting out of the gel receptacle so as to be
graspable. Alternatively, the gel may be provided within the hollow
interior of the main body. A rigid and closed cap seals to either
the main body or the gel receptacle and closes the hollow interior
of the main body.
Inventors: |
Palmer; Timothy A. (Stillwater,
MN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Cure Medical LLC |
Newport Beach |
CA |
US |
|
|
Assignee: |
Cure Medical LLC (Newport
Beach, CA)
|
Family
ID: |
1000004779536 |
Appl.
No.: |
16/827,276 |
Filed: |
March 23, 2020 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
25/0017 (20130101); A61M 25/002 (20130101); A61M
25/0111 (20130101); A61M 2210/1092 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 25/01 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
03008028 |
|
Jan 2003 |
|
WO |
|
012060699 |
|
May 2012 |
|
WO |
|
Primary Examiner: Marcetich; Adam
Attorney, Agent or Firm: SoCal IP Law Group LLP Cumberbatch;
Guy Sereboff; Steven C.
Claims
It is claimed:
1. A urinary catheter package consisting essentially of: a rigid
generally tubular main body having a distal closed end and a
proximal open mouth, the main body defining within itself a hollow
interior; a gel receptacle having a distal section defining an
inner cavity at least partly filled with a lubricating gel and a
proximal section, the distal section having a distal opening and a
proximal opening leading to the proximal section, and the proximal
section having an open proximal end, wherein the gel receptacle is
inserted through the open mouth of the main body and into the
hollow interior, the gel receptacle having an outer circumferential
rib at one end of the proximal section that is sized to interfere
with the open mouth such that the proximal section remains outside
the hollow interior of the main body; a urinary catheter having an
elongated flexible tube defining a closed distal tip with one or
more flow openings formed in an adjacent sidewall thereof, and a
proximal outlet attached to a proximal end of the tube and having a
throughbore in communication with a lumen of the tube, wherein the
tube of the urinary catheter is inserted first into the open
proximal end of the proximal section and extends through the entire
gel receptacle such that the distal tip extends past the distal
opening of the distal section and is within the hollow interior of
the main body and at least a portion of the outlet remains outside
the main body, and wherein a concentric space is formed around the
tube within the distal section of the gel receptacle such that
lubricating gel remains on the catheter tube when the tube is
retracted from within the gel receptacle; and a rigid cap secured
to the proximal section of the gel receptacle, the rigid cap being
solid without openings so as to seal the urinary catheter within
the hollow interior in a sterile manner.
2. The urinary catheter package of claim 1, further including a gel
cap filled with gel that fits over the distal tip of the catheter
tube, the gel cap being larger than the distal opening of the
distal section so that it falls off the end of the tube when the
tube is retracted from within the gel receptacle.
3. The urinary catheter package of claim 2, wherein the gel cap has
a hemispherical cup-shaped body and an outer flange that is larger
than the distal opening of the distal section.
4. The urinary catheter package of claim 1, wherein the distal
opening of the distal section of the gel receptacle is defined by a
plurality of cantilevered fingers separated by longitudinal slots
that may be flexed outward, and the gel receptacle is molded of a
flexible polymer which permits introduction of the lubricant gel
into the inner cavity by inserting a syringe between the catheter
tube and the cantilevered fingers which flex outward.
5. The urinary catheter package of claim 4, wherein the
longitudinal slots commence along the distal section and gradually
widen toward distal ends of the cantilevered fingers.
6. The urinary catheter package of claim 4, wherein the
cantilevered fingers are molded to constrict a distal end of the
distal section, then extend a short linear distance within which is
defined the distal opening, before flaring outward to distal ends
of the cantilevered fingers.
7. The urinary catheter package of claim 1, wherein the catheter
has a length of between about 10-15 cm, and the catheter package
has a length of no more than 1-2 cm longer than the catheter.
8. The urinary catheter package of claim 1, wherein the proximal
section of the gel receptacle has a diameter that is approximately
the same as an inner luminal diameter of the rigid cap such that
the rigid cap is secured to the proximal section with an
interference fit.
9. The urinary catheter package of claim 8, wherein the proximal
section has a pair of external axially-spaced ribs that interfere
with the inner luminal diameter of the rigid cap so as to retain
and seal it on the proximal section.
10. The urinary catheter package of claim 9, wherein the proximal
section is molded with a slight narrowing taper toward the proximal
opening and a proximal rib is sized larger than a distal rib so as
to have about the same diameter as the distal rib.
11. The urinary catheter package of claim 9, wherein the ribs are
triangular and asymmetric in cross-section with a steeper proximal
face than a distal face.
12. A urinary catheter package, comprising: a rigid generally
tubular main body having a distal closed end and a proximal open
mouth, the main body defining within itself a hollow interior; a
gel receptacle having a distal section defining an inner cavity at
least partly filled with a lubricating gel and a proximal section,
the distal section having a distal opening and a proximal opening
leading to the proximal section, and the proximal section having an
open proximal end, wherein the gel receptacle is inserted through
the open mouth of the main body and into the hollow interior,
wherein the gel receptacle is molded of a flexible polymer and the
distal opening of the distal section of the gel receptacle is
defined by a plurality of cantilevered fingers separated by
longitudinal slots that may be flexed outward, wherein the
cantilevered fingers are molded to constrict a distal end of the
distal section, then extend a short linear distance within which is
defined the distal opening, before flaring outward to distal ends
of the cantilevered fingers; a urinary catheter having an elongated
flexible tube defining a closed distal tip with one or more flow
openings formed in an adjacent sidewall thereof, and a proximal
outlet attached to a proximal end of the tube and having a
throughbore in communication with a lumen of the tube, wherein the
catheter has a length of between about 10-15 cm, wherein the tube
of the urinary catheter is inserted first into the open proximal
end of the proximal section and extends through the entire gel
receptacle such that the distal tip extends past the distal opening
of the distal section and is within the hollow interior of the main
body and at least a portion of the outlet remains outside the main
body, wherein the gel receptacle permits introduction of a
lubricant gel into the inner cavity by inserting a syringe between
the tube of the catheter and the cantilevered fingers of the gel
receptacle which flex outward, and wherein a concentric space is
formed around the tube within the distal section of the gel
receptacle such that lubricating gel remains on the catheter tube
when the tube is retracted from within the gel receptacle; and a
rigid cap secured to the proximal section of the gel receptacle,
the rigid cap being solid without openings so as to seal the
urinary catheter within the hollow interior in a sterile
manner.
13. The urinary catheter package of claim 12, further including a
gel cap filled with gel that fits over the distal tip of the
catheter tube, the gel cap being larger than the distal opening of
the distal section so that it falls off the end of the tube when
the tube is retracted from within the gel receptacle.
14. The urinary catheter package of claim 13, wherein the gel cap
has a hemispherical cup-shaped body and an outer flange that is
larger than the distal opening of the distal section.
15. The urinary catheter package of claim 12, wherein the
longitudinal slots commence along the distal section and gradually
widen toward distal ends of the cantilevered fingers.
16. The urinary catheter package of claim 12, wherein the proximal
section of the gel receptacle has a diameter that is approximately
the same as an inner luminal diameter of the rigid cap such that
the rigid cap is secured to the proximal section with an
interference fit.
17. The urinary catheter package of claim 16, wherein the proximal
section has a pair of external axially-spaced ribs that interfere
with the inner luminal diameter of the rigid cap so as to retain
and seal it on the proximal section.
18. The urinary catheter package of claim 17, wherein the proximal
section is molded with a slight narrowing taper toward the proximal
opening and a proximal rib is sized larger than a distal rib so as
to have about the same diameter as the distal rib.
19. The urinary catheter package of claim 17, wherein the ribs are
triangular and asymmetric in cross-section with a steeper proximal
face than a distal face.
Description
NOTICE OF COPYRIGHTS AND TRADE DRESS
A portion of the disclosure of this patent document contains
material which is subject to copyright protection. This patent
document may show and/or describe matter which is or may become
trade dress of the owner. The copyright and trade dress owner have
no objection to the facsimile reproduction by anyone of the patent
disclosure as it appears in the Patent and Trademark Office patent
files or records, but otherwise reserves all copyright and trade
dress rights whatsoever.
FIELD
The present application relates to a sterile rigid package housing
a female pre-lubricated urinary catheter which can be used for
(intermittent) self-catheterization by a patient.
BACKGROUND
Intermittent catheters are typically used by patients suffering
from urinary incontinence or by individuals unable to have
voluntary urination. In our highly mobile culture, the ability to
have the freedom to leave home for the day or longer is an
important part of life. To accommodate this need, single use
catheters have been developed to allow patients to perform
self-catheterization.
A gel container is used as a means to apply gel to a urinary
catheter upon withdrawal of the catheter from a package. Typically,
the gel container is made of a flexible material like molded
silicone. If the container is assembled into a rigid package there
is no way for the user to manipulate the container to ensure
adequate gel coverage of the distal (tip) end of the catheter.
Urinary catheters come in different lengths depending on the user:
There are conventionally three lengths: female (12-26 cm), standard
for men (40-45 cm) and pediatric (30-31 cm).
The Cure Twist available from Cure Medical of Newport Beach, Calif.
is a compact female length catheter packaged in a rigid tube
package with an internal, flexible gel receptacle molded of
silicone rubber. To help reduce the stigma of having to use the
catheter, the Twist package is relatively short and conveniently
resembles a tube for cosmetics, such as eyeliner. The gel
receptacle holds lubricating gel in storage and applies it to the
catheter tubing as the catheter is withdrawn from the package. U.S.
Pat. No. 8,181,778 discloses such a rigid container for a catheter
having a shortened tube with a leading end and a proximal end
provided with a catheter outlet or connector. U.S. Pat. No.
9,687,629 discloses alternative gel receptacles which are shaped so
as to ensure gel covers the extreme distal tip of the catheter. The
user removes the catheter for use, either by joining the connector
to a collection bag or other collection device or by simply using
the catheter while sitting on the toilet. The catheter is
lubricated and ready to use directly from the package.
Though the Cure Twist packaged catheter is convenient and
surreptitious, it includes a number of components that raise its
price, and thus there is a need for a similar product which is
simpler and thus less expensive to make.
SUMMARY OF THE INVENTION
Embodiments of the present invention seek to provide an enhanced
package for a urinary catheter, suitable for everyday use by a
patient.
In one embodiment, a package or container consists essentially of a
rigid generally tubular main body, a urinary catheter and a rigid
cap. The main body has a distal closed end and a proximal open
mouth and defines within a hollow interior. The urinary catheter
has an elongated flexible tube defining a closed distal tip with
one or more flow openings formed in an adjacent sidewall thereof,
and a proximal outlet attached to a proximal end of the tube and
having a throughbore in communication with a lumen of the tube. The
tube of the urinary catheter is inserted through the open mouth of
the main body and into the hollow interior such that at least a
portion of the outlet remains outside the main body. An outer
diameter of the tube is less than an inner diameter of the hollow
interior so that a concentric space is formed therebetween which is
at least partly filled with a lubricating gel to the distal closed
end of the main body such that lubricating gel remains on the
catheter tube when the tube is retracted from within the main body.
The rigid cap secures to the open mouth of the main body, and the
rigid cap is solid without openings so as to seal the urinary
catheter within the hollow interior in a sterile manner.
The rigid cap is preferably secured to the open mouth of the main
body with mating threads. The generally tubular main body may have
a shallow hourglass shape that narrows in a middle portion and the
lubricating gel is deposited only in a distal end of the hollow
interior of the main body to limit the amount of gel that remains
on the catheter tube when retracted from within the main body.
The urinary catheter package may further including a divider wall
secured within the main body and having a central aperture sized
slightly larger than the catheter tube. The divider wall segregates
the hollow interior of the main body into a proximal first section
and a distal second section, wherein the lubricating gel is
deposited only in the distal second section. A diameter D of the
catheter tube preferably ranges between about 2.7-5.3 mm, and a
diameter A of the central aperture is about 1-2 mm larger than the
diameter D. The divider wall may be formed by a molded bulkhead
within the main body, or may be a removable annular disk retained
within the inside of the main body with adhesive or held in place
by a snap fit into a ring-shaped receiving cavity.
A second embodiment of urinary package or container consists
essentially of a rigid generally tubular main body, a gel
receptacle, a urinary catheter and a rigid cap. The main body has a
distal closed end and a proximal open mouth and defining within a
hollow interior. The gel receptacle has a distal section defining
an inner cavity at least partly filled with a lubricating gel and a
proximal section. The distal section has a distal opening and a
proximal opening leading to the proximal section, and the proximal
section has an open proximal end. The gel receptacle is inserted
through the open mouth of the main body and into the hollow
interior, and the gel receptacle has an outer circumferential rib
at one end of the proximal section that is sized to interfere with
the open mouth such that the proximal section remains outside the
hollow interior of the main body. The urinary catheter has an
elongated flexible tube defining a closed distal tip with one or
more flow openings formed in an adjacent sidewall thereof, and a
proximal outlet attached to a proximal end of the tube and having a
throughbore in communication with a lumen of the tube. The tube of
the urinary catheter is inserted first into the open proximal end
of the proximal section and extends through the entire gel
receptacle such that the distal tip extends past the distal opening
of the distal section and is within the hollow interior of the main
body and at least a portion of the outlet remains outside the main
body. A concentric space is formed around the tube within the
distal section of the gel receptacle such that lubricating gel
remains on the catheter tube when the tube is retracted from within
the gel receptacle. The rigid cap secures to the proximal section
of the gel receptacle, the rigid cap being solid without openings
so as to seal the urinary catheter within the hollow interior in a
sterile manner.
The package of the second embodiment may further include a gel cap
filled with gel that fits over the distal tip of the catheter tube,
the gel cap being larger than the distal opening of the distal
section so that it falls off the end of the tube when the tube is
retracted from within the gel receptacle. The gel cap may have a
hemispherical cup-shaped body and an outer flange that is larger
than the distal opening of the distal section. The distal opening
of the distal section of the gel receptacle may be defined by a
plurality of cantilevered fingers separated by longitudinal slots,
and the gel receptacle is molded of a flexible polymer which
permits introduction of the lubricant gel into the inner cavity by
inserting a syringe or other similar implement between the catheter
tube and the cantilevered fingers which flex outward. The
longitudinal slots preferably commence along the distal section and
gradually widen toward the distal ends of the cantilevered fingers.
The urinary catheter package of claim 12, wherein the cantilevered
fingers are molded to constrict a distal end of the distal section,
then extend a short linear distance within which is defined the
distal opening, before flaring outward to distal ends of the
cantilevered fingers.
The proximal section of the gel receptacle may have a diameter that
is approximately the same as an inner luminal diameter of the rigid
cap such that the rigid cap is secured to the proximal section with
an interference fit. The proximal section may have a pair of
external axially-spaced ribs that interfere with the inner luminal
diameter of the rigid cap so as to retain and seal it on the
proximal section. In one embodiment, the proximal section is molded
with a slight narrowing taper toward the proximal opening and a
proximal rib is sized larger than a distal rib so as to have about
the same diameter. The ribs may be triangular and asymmetric in
cross-section with a steeper proximal face than a distal face.
The catheter of either embodiment may have a length of between
about 10-15 cm, and the catheter package has a length of no more
than 1-2 cm longer than the catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a longitudinal sectional view through a sterile container
of the prior art for an intermittent urinary catheter, and
FIG. 2 is an exploded view of the components thereof;
FIG. 3 is a longitudinal sectional view through a sterile container
for an intermittent urinary catheter of the present application,
and
FIG. 4 is an exploded view of the components thereof;
FIG. 5A is a perspective view of a gel receptacle used in the
sterile container of FIG. 3, and FIGS. 5B-5E are sectional and
interviews thereof;
FIG. 6 is a longitudinal sectional view through a sterile container
for an intermittent urinary catheter similar to that shown in FIG.
3, and with the addition of a gel cap for the catheter tube;
FIGS. 7A-7D show several steps in removal of the catheter tube from
within the rigid container shown in FIG. 6, with the end result
being complete coverage of the catheter tube with lubricant
gel;
FIGS. 8A-8B are side elevational views of two different sterile
containers for intermittent urinary catheters;
FIGS. 9A-9B are side elevational views of a further sterile
container for intermittent urinary catheters;
FIG. 10 is a side elevational view of an alternative sterile
container for an intermittent urinary catheter;
FIG. 11 is a sectional view through a gel receptacle which receives
a catheter tube for use in the sterile container of FIG. 10, and
FIG. 11A is an enlarged view of an open end of the gel receptacle
and catheter;
FIG. 12 is an exploded view of the catheter tube removed from the
gel receptacle of FIG. 12 showing complete coverage of the catheter
tube with lubricant gel;
FIGS. 13A and 13B are orthogonal views of the gel receptacle of
FIG. 12;
FIG. 14 is a longitudinal sectional view through an alternative
sterile container for an intermittent urinary catheter; and
FIGS. 14A-14B are exploded views of alternative configurations of
the components of the sterile container of FIG. 14.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
The present application provides an easy to use and easy to carry
solution for providing a medical device in the form of a
catheter.
FIG. 1 illustrates a cross sectional view of a prior art
intermittent catheter container 20 such as shown in U.S. Pat. No.
8,181,778, with all elements assembled. Catheter container 20
includes a pen-like rigid and generally hollow tubular main body 22
which is closed off at a distal end 23 thereof, and which can be
closed off at a proximal, open end using a cap 24.
The cross-sectional view of main body 22 shows a proximal first
part 26a, a middle second part 26b and distal third part 26c, which
have respective diameters as described in U.S. Pat. No. 8,181,778.
It should be noted that the direction "proximal" is defined as the
direction in which a urinary catheter 30 is withdrawn from the main
body 22. Preferably, first part 26a has a first inner diameter
which is less than second inner diameter of second part 26b, and
third part 26c has a third inner diameter which is less than second
inner diameter of second part 26b. In other words, the middle
second part 26b has a larger diameter than either of the proximal
or distal parts.
The main body 22 is desirably an assembly of a long distal portion
with a shorter tubular connector (that forms the third part 26a)
bonded thereto for ease of molding (see FIG. 2). The rigid cap 24
can be attached to the connector 26a of the main body 22 using
various attachment/locking methods, such as a screw thread, a
bayonet closure or a clamping arrangement. The cap 24 desirably has
a plurality of openings (not shown) to permit the introduction of a
sterilizing gas into the catheter package.
As illustrated, the urinary catheter 30 is stored in a sterile
condition within the main body 22 with the cap 24 on. At a proximal
end thereof, catheter 30 is provided with a catheter outlet 32
having a throughbore, which may be used as an outlet funnel or as a
connector to attach the catheter 30 to a collection bag or other
collection device. Catheter 30 includes a flexible catheter tube 34
provided with a rounded tip 35 on a distal end and one or more flow
openings 36 proximate the tip. The catheter tube 34 has a lumen in
fluid communication with the throughbore of the outlet 32. Openings
36 are provided with rounded and or polished edges 38, such that
the entry of urinary catheter tube 34 into the urethral tract of a
patient is as comfortable as possible for the patient. The first
part 26a of the main body receives the cap 24, the second part 26b
holds a gel receptacle 40, and the third part 26c holds the
elongated catheter tube 34 of the catheter 30.
The rigid nature of the container 20 and short length of the
catheter 30 therein make the sterile package formed by the assembly
highly portable and conveniently stored in a purse or even
pocket.
The cap 24 contains the proximal outlet 32 of the catheter 30 and
may be made of a transparent material, which allows inspection of
the outlet 32 (which can, e.g., show size or other indicia,
markings, etc.). To facilitate gas sterilization of the components
inside the main body 22 with the cap 24 attached, cap 24 is
provided with one or more openings 23 that are sealed off with
filter element 25, e.g. in the form of a paper or other porous
element. For instance, a spun bonded polyolefin material (sold
under the tradename Tyvek) may be used which can be heat welded to
the cap 24 to provide a seal. After assembling the main body 22
(including bonding the connector 26c), gel container 40, catheter
30 and cap 24, the internal elements of the package are sterilized
by introducing a gas such as ethylene oxide through the one or more
openings 23 in cap 24.
The dimensions of container 20 (or more specifically, the internal
dimensions of main body 22 and cap 24) are adapted to allow storage
of the entire catheter 30 (which may have varying dimensions). A
length of the container 20 desirably corresponds closely to the
length of catheter 30, and is preferably slightly greater than the
length of catheter 30 so that the package closely surrounds the
entire catheter 30. In accordance with embodiments, catheter 30 can
have a length in a range of between about 10-15 cm, which makes
catheter 30 especially suited for use with female patients.
The gel receptacle 40 is provided and positioned in second part 26b
of main body 22. Gel receptacle 40 is illustrated as a single
generally tubular element provided with a cavity 42 in which an
amount of a gel-like lubricant agent G is stored. As seen in FIG.
2, gel receptacle 40 includes distal opening 44 at a distal end
thereof, and proximal opening 46 at a proximal end thereof. Distal
opening 44 has a diameter corresponding generally to outer diameter
of catheter tube 34, while proximal opening 46 has a diameter
slightly greater than the outer diameter of catheter tube 34. The
distal and proximal openings 44, 46 are aligned with each other
along a longitudinal centerline 50 extending between the distal and
proximal ends of the gel receptacle 40. When taking or otherwise
removing catheter 30 in a proximal direction out of the package (to
the right in FIG. 1), a layer of the gel-like lubricant extrudes
through proximal opening 46 and is deposited on the outside surface
of the catheter for use.
FIG. 3 is a longitudinal sectional view through a sterile container
50 for an intermittent urinary catheter of the present application,
FIG. 4 is an exploded view of the components thereof, and FIGS.
5A-5E are perspective and other views of a gel receptacle used in
the sterile container. The sterile container 50 is utilized in much
the same manner as the container 20 described above, but is
constructed and assembled in a more straightforward and less costly
manner.
The sterile catheter container 50 includes a pen-like, rigid and
generally hollow tubular main body 52 which is closed off at a
distal end, and which can be closed off at a proximal, open end
using cap 54. The rigid cap 54 can be attached to the main body 52
using various attachment/locking methods, such as a screw thread, a
bayonet closure or a clamping arrangement. The end 53 of the cap 54
is solid and closes off the proximal open end of the main body 52
to prevent the introduction of air or other contaminants into the
hollow interior of the catheter package. Sterilization prior to
shipping is accomplished using gamma rays or an electron-beam.
The cross-sectional view of main body 52 shows a proximal first
section 56a and a distal second section 56b. Preferably, proximal
section 56a has a first inner diameter which is greater than a
second inner diameter of distal section 56b. Both sections 56a, 56b
are generally tubular to as to define cylindrical hollow
interiors.
As illustrated, with the cap 54 on, a urinary catheter 60 is stored
in a sterile condition within the main body 52. At a proximal end
thereof, catheter 60 is provided with a catheter outlet 62, which
may be used as an outlet funnel or as a connector to attach the
catheter 60 to a collection bag or other collection device.
Catheter 60 includes a flexible catheter tube 64 provided with a
rounded tip 65 on a distal end and one or more flow openings 66
proximate the tip. Openings 66 are provided with rounded and or
polished edges, such that the entry of urinary catheter tube 64
into the urethral tract of a patient is as comfortable as possible
for the patient.
The rigid nature of the container 50 and short length of the
catheter 60 therein make the sterile package formed by the assembly
highly portable and conveniently stored in a purse or even pocket,
as it resembles a standard item of cosmetics such as eyeliner.
An elongated gel receptacle 70 is provided and positioned in the
main body 52. The tube 64 of the urinary catheter 60 extends
through the entire gel receptacle 70 such that the distal tip 65 is
within the hollow interior of the main body 52.
Gel receptacle 70 is illustrated as a single generally tubular
molded polymer element provided with a distal inner cavity 72 in
which an amount of a gel-like lubricant agent is stored. As seen in
FIG. 4, gel receptacle 70 includes distal opening 74 at a distal
end thereof, and proximal opening 76 at a proximal end thereof.
Distal opening 74 has a diameter corresponding generally to an
outer diameter of catheter tube 64, while proximal opening 76 has a
diameter slightly greater than the outer diameter of catheter tube
64. The distal and proximal openings 74, 76 are aligned with each
other along a longitudinal centerline 50 extending between the
distal and proximal ends of the gel receptacle 70. When the cap 54
is removed the proximal outlet 62 projects out of the gel
receptacle 70 so as to be graspable. When removing catheter 60 in a
proximal direction out of the package (to the right in FIG. 3), a
layer of the gel-like lubricant extrudes through proximal opening
76 and is deposited on the outside surface of the catheter tube 64
for use.
As seen best in FIGS. 5A-5E, the gel receptacle 70 comprises three
generally tubular sections: a proximal section 80a, a middle
section 80b, and a distal section 80c. The inner cavity 72 is
formed exclusively within the distal section 80c. The proximal and
middle sections 80a, 80b are generally coextensive and of the same
diameter, and are delineated by an outer circumferential rib 82.
The distal section 80c is of a smaller diameter than the proximal
and middle sections 80a, 80b, and separated therefrom by a tapered
shoulder 83.
As seen in FIG. 3, the gel receptacle 70 inserts into the open
proximal end of the rigid main body 52 such that the smaller
diameter distal section 80c reaches a short distance into the
distal section 56b of the main body 52. The middle section 80b has
an outer diameter similar to an inner diameter of the proximal
section 56a of the main body 52, while the outer circumferential
rib 82 is sized the same as the proximal section 56a so as to
provide a stop preventing further advancement of the gel receptacle
70 into the container main body 52. The proximal section 80a
extends out of the main body 52 and provides a tubular receiver for
the cap 54, as will be described. During assembly, the gel
receptacle 70 may be secured in this partially inserted position
using adhesives, for example, between the exterior of the middle
section 80b and the interior of the proximal section 56a of the
main body 52.
Namely, the proximal section 80a features two circumferential ribs
90, 92, as seen in FIGS. 5A-5D. The nominal outer diameter proximal
section 80a is approximately the same as an inner luminal diameter
of the tubular portion of the cap 54, while the ribs 90, 92 are
larger and interfere with the cap so as to retain and seal it on
the proximal section. As seen in the enlargements of FIGS. 5C and
5D, the ribs 90, 92 are slightly different, with the proximal rib
90 being larger, and the distal rib 92 being slightly smaller,
though both are asymmetric in cross-section. In particular, the
ribs 90, 92 have a steeper proximal face than a distal face, which
helps to facilitate removal of the cap 54 when desired. The less
steep distal face gives more support to the proximal face during
cap assembly to prevent the rib from rolling. The ribs 90, 92 needs
to "shear" at the apex to create an airtight seal between cap and
body. The proximal rib is sized larger due to the draft (taper)
that narrows toward the proximal opening 86 needed to mold the
proximal section 80a. The size difference keeps the top of the ribs
at the same plane to meet the cap which has an inner lumen molded
with no draft (cylindrical).
The cap 54 surrounds the proximal outlet 62 of the catheter 60 and
may be made of a transparent material, which allows inspection of
the outlet 62 (which can, e.g., show size or other indicia,
markings, etc.). To prevent contamination of the components inside
the main body 52 with the cap 54 attached, cap 54 is solid with no
openings, in contrast to the Twist catheter which has a porous cap.
After assembling main body 52, gel container 70, catheter 60 and
cap 54, and adding gel to the gel container 70, the internal
elements of the package are sterilized by exposure to gamma rays or
an electron-beam.
The dimensions of container 50 (or more specifically, the internal
dimensions of main body 52 and cap 54) are adapted to allow storage
of the entire catheter 60 (which may have varying dimensions). A
length of the container 50 desirably corresponds closely to the
length of catheter 60, and is preferably slightly greater than the
length of catheter 60 so that the package closely surrounds the
entire catheter 60. In accordance with embodiments, catheter 60 can
have a length in a range of between about 10-15 cm, which makes
catheter 60 especially suited for use with female patients. The
entire container 50 preferably has a length of no more than 1-2 cm
longer than the catheter 60. So, a 10 cm long catheter would be
packaged in a container 50 of between 11-12 cm, and a 15 cm long
catheter would be packaged in a container 50 of between 16-17
cm.
As mentioned, inner cavity 72 of gel receptacle 70 includes distal
opening 74 at a distal end thereof, and proximal opening 76 at a
proximal end thereof. It should be understood that these openings
are at the ends of the distal section 80c within which is defined
the inner cavity 72.
The overall gel receptacle 70 has a distal end 84 and a proximal
end 86. As seen in FIG. 5A, the distal end 84 is defined by a
plurality of cantilevered fingers 94 separated by longitudinal
slots 96. The slots 96 commence along the distal section 80c and
gradually widen toward the distal end of the fingers 94. With
reference to the sectional view of FIG. 5B, the distal end 84
formed by the fingers 94 is molded to constrict the distal end of
the distal section 80c, then extend a short linear distance within
which is defined the distal opening 74, before flaring outward to
the distal end of the fingers 94. As stated, the distal opening 74
has approximately the same diameter as the outer diameter of the
catheter tube 64 and as such makes surrounding contact therewith to
hold the gel within the inner cavity 72. The cantilevered fingers
94 are molded of a flexible polymer which permits introduction of
the lubricant gel into the cavity 72 by inserting a syringe or
other such implement between the catheter tube 64 and fingers 94,
which flex outward.
By comparing the cross-sections of FIGS. 1 and 3 and respective
exploded views of FIGS. 2 and 4, certain distinct advantages
between the containers 20, 50 are apparent. First of all, aside
from the catheter 60 itself, there are only three molded components
in the sterile container 50 as compared with four components with
the prior art container 20. Similarly, the gel container 40 of the
prior art must be forced into the cavity in the middle part 26b and
then filled with gel through the open end of the main body 22
before the catheter 30 is inserted, a dual-action operation that is
somewhat exacting and thus time-consuming and expensive.
Conversely, the catheter 60 of the present container 20 is first
inserted through the gel container 70, and then gel is inserted
past the flexible fingers 94 and into the inner cavity 72. This
gel-filled assembly is then directly inserted into the rigid main
body 52 until the circumferential rib 82 contacts the rear end of
the proximal section 56a. Finally, the catheter package described
herein is completed by adding the cap 54, while the prior art cap
24 must first be combined with the filter element 25, adding
another manufacturing step.
In short, the manufacturing advantages of the present container 50
are significant and reduce the costs in a meaningful way in a
product whose profit margins are relatively thin to start with.
Profit margins are low due to federal government oversight on
reimbursement levels for this product. Once the government sets a
reimbursement rate, other insurers quickly set their rates at
60-85% of the govt rate. The improved design also lends itself to
automation which the prior art design does not mainly due to the
difficulty of filling gel once the gel holder is assembled to the
tube. This reduces manufacturing costs, which although slight, has
a disproportionate impact on profit.
FIG. 6 is a longitudinal sectional view through the sterile
container 50 for an intermittent urinary catheter with the addition
of a gel cap 100 for the catheter 60, and FIGS. 7A-7D show several
steps in removal of the catheter tube from within the rigid
container 50, with the end result being complete coverage of the
catheter tube with lubricant gel G.
In some cases, removal of the catheter 60 from within the container
50 may not completely cover the distal tip of the catheter tube
with gel, resulting in a dry tip which may hinder introduction into
the urethra. Consequently, the gel cap 100 is provided. The gel cap
100 includes a hemi-spherical cup filled with gel that fits over
the distal tip of the catheter 60. The gel cap 100 may be added
after the catheter 60 is assembled with the gel container 70 as
described above, and preferably after filling the inner cavity 72
with gel. The gel cap 100 remains stuck on the end of the catheter
60 during shipping and handling of the container 50 by the customer
by virtue of the viscosity of the gel inside.
FIGS. 7A-7D show several steps in removal of the catheter 60 from
the container 50. As the catheter tube 64 slides out of the gel
container 70, gel G coats the outer surface thereof. At the
position shown in FIG. 7B, a circular flange 102 on a proximal end
of the gel cap 100 contacts the distal end 84 of the gel container
70 within the main body 52. Further withdrawal of the catheter 60
causes the gel cap 100 to fall off the end of the tube 64, as seen
in FIG. 7C. Gel G coats the end of the tube 64. Finally, after
complete withdrawal, the distal end catheter tube 64 is totally
coated with gel G on the distal end and for most of its length.
This facilitates introduction into the urethra, and eliminates the
occasional problem of a dry tip.
FIGS. 8A-8B are side elevational views of two different sterile
containers 110 for intermittent urinary catheters. The two
containers 110 are identical except for different cap closures. The
containers 110 include a generally tubular main body 112 having a
lower closed end opposite an upper open end. A closed cap 116
engages the upper open end of each main body 112 to seal the
interior thereof. In FIG. 8A, the cap 116 engages the main body
through friction or with interfering ribs, as described above,
while in FIG. 8B the cap 116 has a series of internal threads which
engage external threads on the mouth of the main body.
The tube of the catheter 114 extends down into the hollow interior
defined within each of the main bodies 112. The tube is smaller
than the inner diameter of the hollow interiors so as to form
concentric spaces 118 therebetween. A lubricating gel (not shown)
is provided within the spaces 118 prior to insertion of the
catheter 114, such that when the user removes the catheter it is
gel coated and ready for use. It should be noted that the inner
lumen of the main body 112 is substantially cylindrical down to a
rounded dead end 113, but has a tapered upper portion 115 opening
to the upper mouth. The catheter 114 has a tapered outlet or funnel
117 which fits closely within the upper portion 115. Additionally,
an elastomeric seal or collar 119 is provided at the bottom of the
funnel 117 (and is preferably molded therewith) which is sized to
engage the cylindrical portion of the main body lumen. The collar
119 thus seals any gel within the concentric space 118.
FIGS. 9A-9B are side elevational views of a further sterile
container 120 for intermittent urinary catheters. As before, the
container 120 includes a generally tubular yet inwardly-tapered
main body 122 having a lower closed end opposite an upper open end
and a hollow interior. A closed cap 126 engages the upper open end
of each main body 122 to seal the interior thereof through
friction, with interfering ribs, or with mating threads as
shown.
The tube of the catheter 124 extends down into the hollow interior
defined within the main body 122. The tube is smaller than the
inner diameter of the hollow interior so as to form a concentric
space 128 therebetween. A lubricating gel (not shown) is provided
within the space 128 prior to insertion of the catheter 124, such
that when the user removes the catheter it is gel coated and ready
for use. The inwardly-tapered main body 122 and inner space 128
constrict in the middle portion and the lubricating gel is
deposited only in the distal end of the hollow interior of the main
body 122 which helps reduce the amount of gel that is removed upon
catheter removal, thus helping to reduce mess. It should be noted
that the inner lumen of the main body 122 has a shallow hourglass
shape down to a rounded dead end 123, but has a tapered upper
portion 125 opening wider to the upper mouth. The catheter 124 has
a tapered outlet or funnel 127 which fits closely within the upper
portion 125 and is in fluid communication with the catheter lumen.
Additionally, an elastomeric seal or collar 129 is provided at the
bottom of the funnel 127 (and is preferably molded therewith) which
is sized to engage the narrowing portion of the main body lumen.
The collar 129 thus seals any gel within the concentric space 128.
The main body 122 further includes an angled distal end 130 through
which the distal tip of the catheter 124 can be viewed. The angled
distal end 130 may also be squared off, depending on manufacturing
constraints.
FIG. 10 is a side elevational view of a still further sterile
container 140 for an intermittent urinary catheter. The outer
components of the container 140 include a tapered main body 142
which may be closed by a cap 144, such as with mating threads. FIG.
11 is a sectional view of a catheter having an outlet 150 on the
proximal end of a catheter tube 152 which is inserted within a
generally tubular gel receptacle 154 with a closed distal end. The
assembly of the gel receptacle 154 and catheter is seen placed
within the hollow interior of the main body 142 of the container
140 in FIG. 10. In a preferred embodiment, the gel receptacle 154
has a tapered configuration which fits closely within the tapered
main body 142. An outwardly projecting circular flange 156 at the
top of the tapered gel receptacle 154 is sized to contact the
gradually narrowing inner walls of the main body 142 in an
interference fit so as to secure the gel receptacle within the main
body. Alternatively, the flange 156 may be forced past a small
inward circular rib (not shown) within the gel receptacle 154 to
ensure the gel receptacle 154 remains within the main body 142.
The circular flange 156 defines a central opening through which the
catheter tube 152 is inserted into an inner cavity of the gel
receptacle. An annular seal or collar 157 at the base of the
catheter outlet 150 that is larger than the central opening helps
maintain the gel G within the cavity of the gel receptacle 154. As
with certain other embodiments described herein, a concentric space
is provided around the catheter tube 152 within the inner space
which may be filled with lubricant gel G. The central opening in
the circular flange 156 has an inner diameter A, shown in FIG. 11A
which is slightly larger than the outer diameter D of the catheter
tube 152. When the user withdraws the catheter from within the gel
receptacle 154, gel G coats the exterior of the catheter tube 152,
as seen in FIG. 12. The spacing created between the catheter tube
152 and the central opening wipes off a majority of the gel G which
might otherwise stick to the tube but leaves a thin coating
thereon. In one embodiment, the diameter D of the catheter tube 152
ranges between 8-16 French, or between about 2.7-5.3 mm (3 Fr=1
mm). The diameter A of the central opening is desirably about 1-2
mm larger than the corresponding catheter tube diameter, or between
3.7-7.3 mm. Since the entirety of the inner cavity of the gel
reservoir 154 is filled with gel G, the distal tip of the catheter
to 152 emerges covered with gel as well.
Radial score lines 158 allow for molding of the gel holder 154.
There is an undercut design for the flange 156 and the score lines
158 allow for removal of the mold core by allowing the flange to
flex open during part ejection.
FIG. 14 is a longitudinal sectional view through an alternative
sterile container 160 for an intermittent urinary catheter. In this
version, the container 160 includes a generally tubular main body
162 closed at one end and open at the other. The catheter tube 164
inserts within the open end of the main body 162 such that an
outlet 166 remains outside. A cap 168 is then secured around the
main body 162 using any of the means described herein. The cap 168
preferably has a solid end 170.
A barrier or divider wall 172 segregates the inner volume of the
main body 162 into a proximal first section 174 and a distal second
section 176. The divider wall 172 is a central aperture sized
slightly larger than the outer diameter of the catheter tube 164,
such that the tube is passed through the aperture and a distal
portion resides within the second section 176, which may be filled
with gel G. The divider wall 172 thus helps retain the gel G in the
distal end of the closed main body 162 to reduce mess when
withdrawing the catheter. As the catheter is withdrawn, it emerges
coated with gel G along its distal length and distal tip. The
difference in diameter between the aperture of the divider wall 172
and the outer diameter of the catheter tube 164 may be the same as
described above for the gel receptacle 154 of FIG. 11. That is, the
diameters A and B may be the same in the embodiment of FIGS. 14 and
14A-14B.
FIGS. 14A-14B are exploded views of alternative configurations of
the components of the sterile container 160 of FIG. 14. In the
first embodiment of FIG. 14A, the divider wall 172 is formed by a
molded bulkhead within the main body 162. Conversely, in the
embodiment shown in FIG. 14B, the divider wall 172 is a removable
annular disk. This embodiment is slightly easier to manufacture,
though accommodation must be made to retain the disk 172 within the
main body 162. In one embodiment, the annular disk 172 is retained
within the inside of the main body 162 with adhesive. In another
embodiment the disk is held in place by a snap fit into a
ring-shaped receiving cavity.
In each of the embodiments shown in FIGS. 8-14, the catheter can
have a length in a range of between about 10-15 cm, which makes the
catheter especially suited for use with female patients. The entire
container preferably has a length of no more than 1-2 cm longer
than the catheter. So, a 10 cm long catheter would be packaged in a
container of between 11-12 cm, and a 15 cm long catheter would be
packaged in a container of between 16-17 cm.
Throughout this description, the embodiments and examples shown
should be considered as exemplars, rather than limitations on the
apparatus and procedures disclosed or claimed. Although many of the
examples presented herein involve specific combinations of method
acts or system elements, it should be understood that those acts
and those elements may be combined in other ways to accomplish the
same objectives. Acts, elements and features discussed only in
connection with one embodiment are not intended to be excluded from
a similar role in other embodiments.
* * * * *